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UVA Brain and Aortic Aneurysm Study (BAAS)

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ClinicalTrials.gov Identifier: NCT02869464
Recruitment Status : Unknown
Verified August 2016 by Bradford Worrall, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : August 17, 2016
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Bradford Worrall, MD, University of Virginia

Brief Summary:
The purpose of this study is to examine the percentage of patients who present with abdominal aortic aneurysms (AAA) will also have intracranial aneurysms (IA) and conversely; to examine the percentage of patients who present with intracranial aneurysms will also have abdominal aortic aneurysms.

Condition or disease Intervention/treatment
Intracranial Aneurysm Abdominal Aortic Aneurysm Other: Imaging-Ultrasound Other: Imaging-MRA Genetic: DNA, RNA testing

Detailed Description:
The investigators have previously generated estimates for cost effectiveness of each arm of this reciprocal screening protocol based on literature dervied estimates of coprevalence and other key factors in a decision tree model to compare costs and outcomes. They measured expected outcomes using quality-adjusted life years (QALY) and the incremental cost-effectiveness ratios (ICER). The current study will involve establishment of the true co-prevalence and recalculation of the ICERs and QALYs. Based on their literature derived models we previously found an ICER of $34.01/QALY for AAA screening in IA patients and an ICER of $6,401.91/QALY for IA screening in AAA patients. Both of these are well below the societal accepted threshold of $60,000/QALY. However, both models were sensitive to co-prevalence. In the current study the investigators will therefore determine the actual cost-effectiveness of performing additional radiographic procedures and genetic counseling. The investigators will also bank DNA and RNA for future research.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: The University of Virginia Brain and Aortic Aneurysm Study
Study Start Date : April 2014
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients presenting with IA
These patients will undergo an abdominal ultrasound (Imaging - Ultrasound) to test for abdominal aortic aneurysm(s). RNA, DNA testing will be planned on banked samples
Other: Imaging-Ultrasound
Abdominal Ultrasound

Genetic: DNA, RNA testing
To test for the co-prevalence of shared genetic markers in afflicted populations.

Patients presenting with AAA
These patients will undergo a non-contrast enhanced magnetic resonance angiogram (MRA) (Imaging - MRA) to test for intracranial aneurysm(s). RNA, DNA testing will be planned on banked samples
Other: Imaging-MRA
Non-contrast Enhanced Magnetic Resonance Angiogram

Genetic: DNA, RNA testing
To test for the co-prevalence of shared genetic markers in afflicted populations.




Primary Outcome Measures :
  1. Revised cost-effective analysis measured in dollars/quality adjusted life years (QALY) [ Time Frame: 2 years ]
    Revision of cost effective analysis for screening for AAA in those presenting with IA and for screening for IA in those with AAA.


Secondary Outcome Measures :
  1. Analysis of Covariates for co-prevalence of aneurysms measured as present or absent [ Time Frame: Year 2 ]
    Analysis of covariates associated with co-prevalence of aneurysms in both territories.

  2. Biorepository (samples stored in freezer) [ Time Frame: Year 2 ]
    Develop a biorepository of DNA and RNA for individuals presenting with either IA or AAA, allowing specific future testing of shared genetic risk factors.


Biospecimen Retention:   Samples With DNA
Approximately 3 mL of blood are obtained via venipuncture at the time of subject consent for banking and future research.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been diagnosed with either a IA or AAA.
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Clinical and radiographic diagnosis of either abdominal aortic aneurysm (AAA) or intracranial cerebral aneurysm (IA). Aneurysm may be symptomatic (s/p rupture or mass effect) or asymptomatic (detected as part of screening or incidentally discovered. Aneurysms int he brain may be multiple. AAA will be defined as >= 3 cm by any imaging modality. IA will be defined as >= 3 mm on any imaging modality.
  • Able to provide a valid informed consent (self or legally authorized representative)

Exclusion Criteria:

  • Contra-indication for MRI/A (embedded metal, intractable claustrophobia, pacemaker, etc.)
  • Intracranial aneurysm associated with arteriovenous malformation
  • Clinical or radiographic diagnosis of mycotic aneurysm
  • Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment or other outcome assessment.
  • Other serious conditions that make the patient unlikely to survive long enough to benefit from the screening program.
  • Inability to follow the protocol or return for screening test or genetic counseling.
  • Unwilling to have reports from imaging and genetic counselor sent to a clinician (PCP, testing surgeon, etc)

Note: Pregnancy is not a reason to exclude, but imaging done for the study will be postponed until after the subject has given birth.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869464


Contacts
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Contact: Claire L McKinley, C.C.R.P. 434-924-9271 cw9ne@hscmail.mcc.virginia.edu
Contact: Julia Krupa, M.S. 434-924-4023 jkk8d@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Claire L McKinley, C.C.R.P.    434-924-9271    cw9ne@virginia.edu   
Contact: Julia K Krupa, M.S.    434-924-4023    jkk8d@virginia.edu   
Principal Investigator: Bradford B Worrall, M.D.         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Bradford B Worrall, MD, MSc University of Virginia
Additional Information:

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Responsible Party: Bradford Worrall, MD, Bradford B. Worrall, M.D., University of Virginia
ClinicalTrials.gov Identifier: NCT02869464    
Other Study ID Numbers: 17341
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Summary data will be shared and published.
Keywords provided by Bradford Worrall, MD, University of Virginia:
Aneurysm
Intracranial Aneurysm
Abdominal Aortic Aneurysm
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases